Aromatherapy for Procedural Anxiety in Pain Management and Interventional Spine Procedures

Weill Medical College of Cornell University1 site in 1 country109 target enrollmentJanuary 29, 2020

ConditionsSpine Injuries and Disorders Pain, Back

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Spine Injuries and Disorders
Sponsor: Weill Medical College of Cornell University
Enrollment: 109
Locations: 1
Primary Endpoint: Change in Subjects' Anxiety State as measured by the State Trait Anxiety Inventory (STAI-6)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Patient anxiety prior to invasive procedures poses a significant barrier to successful treatment if not well-managed. The purpose of this study is to evaluate lavender aromatherapy, a non-sedating alternative, to reduce anxiety prior to interventional spinal procedures.

Registry

clinicaltrials.gov

Start Date

January 29, 2020

End Date

November 18, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Weill Medical College of Cornell University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males and females between 18-85 years old
•Scheduled for one of the following procedures on the day of consent:
•Epidural steroid injection (ESI)
•Medial branch block (MBB)
•Radiofrequency ablation (RFA)
•Able to provide informed consent

Exclusion Criteria

•History of anxiety disorder
•Currently on anxiolytic therapy
•Poor sense of smell
•Allergy/aversion to aromatherapy
•Non-English speaking

Outcomes

Primary Outcomes

Change in Subjects' Anxiety State as measured by the State Trait Anxiety Inventory (STAI-6)

Time Frame: Administered within 30 minutes before and 30 minutes after intervention

The STAI-6 is a six-item assessment of state anxiety. Each item is assessed on a four-point Likert scale. Scores on the STAI-6 range from 6-24, with a higher score indicating greater state anxiety.

Secondary Outcomes

Number of Vasovagal Events during Standard of Care Spine Procedure(Assessed within 30 minutes following the standard of care spine procedure)
Number of Aborted Standard of Care Spine Procedures(Assessed within 30 minutes following standard of care spine procedure completion or abortion)